Trial Outcomes & Findings for Safety and Exploratory Efficacy Study of SF0166 for the Treatment of Diabetic Macular Edema (DME) (NCT NCT02914613)
NCT ID: NCT02914613
Last Updated: 2023-05-11
Results Overview
Percentage of subjects with red blood cell counts in the anterior chamber in the ranges from 0 to \> 30 with the higher number being worse
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline, 2, 4, 6, and 8 weeks
Results posted on
2023-05-11
Participant Flow
Participant milestones
| Measure |
SF0166 High Dose 5.0% BID
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 Low Dose 2.5% BID
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
SF0166 High Dose 5.0% BID
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 Low Dose 2.5% BID
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Safety and Exploratory Efficacy Study of SF0166 for the Treatment of Diabetic Macular Edema (DME)
Baseline characteristics by cohort
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
67.2 years
STANDARD_DEVIATION 9.8 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Iris Color
Blue
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Iris Color
Brown
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Iris Color
Green
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Iris Color
Hazel
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, 6, and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Percentage of subjects with red blood cell counts in the anterior chamber in the ranges from 0 to \> 30 with the higher number being worse
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) - No cells seen
|
22 Participants
|
22 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) - No cells seen
|
22 Participants
|
22 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) - No cells seen
|
21 Participants
|
21 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) - No cells seen
|
21 Participants
|
21 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) - No cells seen
|
20 Participants
|
19 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) - No cells seen
|
20 Participants
|
19 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) - No cells seen
|
19 Participants
|
20 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) - No cells seen
|
19 Participants
|
20 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) - No cells seen
|
20 Participants
|
20 Participants
|
|
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) - No cells seen
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, 6, and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with flare in the anterior chamber graded on a scale from 0 (none) to 4 (severe).
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, 6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with hyphema
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Absent
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Absent
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Absent
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Absent
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Absent
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Absent
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Absent
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Mild
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Absent
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Absent
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Absent
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with bulbar conjunctival injection
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Absent
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Absent
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Absent
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Mild
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Absent
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Absent
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Absent
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Absent
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Absent
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Absent
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Absent
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, 6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with erythema
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Absent
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Mild
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Absent
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Absent
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Absent
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Absent
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Absent
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Absent
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Absent
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Absent
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Absent
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4, 6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with edema
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Mild
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Absent
|
21 Participants
|
22 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Moderate
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Mild
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Absent
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Mild
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Absent
|
20 Participants
|
21 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Moderate
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Absent
|
20 Participants
|
21 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Absent
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Absent
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Absent
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Absent
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Absent
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Mild
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Absent
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with any lens opacity
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · Any opacity in the lens
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Study Eye) · No opacity in the lens
|
9 Participants
|
15 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · Any opacity in the lens
|
15 Participants
|
9 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Baseline (Fellow Eye) · No opacity in the lens
|
7 Participants
|
13 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · Any opacity in the lens
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Study Eye) · No opacity in the lens
|
9 Participants
|
14 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Any opacity in the lens
|
14 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 2 (Fellow Eye) · No opacity in the lens
|
7 Participants
|
13 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · Any opacity in the lens
|
13 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Study Eye) · No opacity in the lens
|
7 Participants
|
11 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Any opacity in the lens
|
14 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 4 (Fellow Eye) · No opacity in the lens
|
6 Participants
|
11 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · Any opacity in the lens
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Study Eye) · No opacity in the lens
|
9 Participants
|
13 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Any opacity in the lens
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 6 (Fellow Eye) · No opacity in the lens
|
7 Participants
|
13 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · Any opacity in the lens
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Study Eye) · No opacity in the lens
|
9 Participants
|
12 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Any opacity in the lens
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Week 8 (Fellow Eye) · No opacity in the lens
|
7 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with abnormal findings in the optic nerve
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
21 Participants
|
22 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
20 Participants
|
21 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects (both eyes) with abnormal findings in the vitreous
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
18 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
17 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
16 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
16 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
16 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
17 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
15 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with abnormal findings in the fundus
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
4 Participants
|
8 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
16 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with abnormal findings in the macula/choroid
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
21 Participants
|
22 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
20 Participants
|
21 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
18 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with abnormal findings in the retinal vessels
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Normal
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Abnormal
|
17 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Abnormal
|
18 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · Normal
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · Abnormal
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · Normal
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Abnormal
|
18 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · Normal
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Abnormal
|
17 Participants
|
17 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · Normal
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Abnormal
|
17 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · Normal
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Abnormal
|
16 Participants
|
15 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · Normal
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Abnormal
|
16 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · Normal
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Abnormal
|
15 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · Normal
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Abnormal
|
18 Participants
|
16 Participants
|
|
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · Normal
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Number and percentage of subjects with specified Cup:Disc ratio in the range from 0.1 to 0.6 with the higher number being worse
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.60
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.20
|
5 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.30
|
8 Participants
|
10 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.40
|
1 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.10
|
1 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.20
|
6 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.30
|
9 Participants
|
10 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Study Eye) · 0.40
|
2 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.20
|
6 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.30
|
10 Participants
|
13 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.40
|
2 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Baseline (Fellow Eye) · 0.60
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.10
|
1 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.20
|
6 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.30
|
8 Participants
|
10 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.40
|
2 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Study Eye) · 0.60
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.20
|
6 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.30
|
10 Participants
|
13 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.40
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 2 (Fellow Eye) · 0.60
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.40
|
2 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Study Eye) · 0.60
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.20
|
5 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.30
|
10 Participants
|
12 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.40
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 4 (Fellow Eye) · 0.60
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.20
|
6 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.30
|
7 Participants
|
10 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Study Eye) · 0.60
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.20
|
6 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.30
|
9 Participants
|
12 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.40
|
0 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 6 (Fellow Eye) · 0.60
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.20
|
6 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.30
|
7 Participants
|
10 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.40
|
2 Participants
|
4 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.50
|
3 Participants
|
1 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Study Eye) · 0.60
|
0 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.10
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.20
|
6 Participants
|
2 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.30
|
9 Participants
|
12 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.35
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.40
|
1 Participants
|
3 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.50
|
1 Participants
|
0 Participants
|
|
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Week 8 (Fellow Eye) · 0.60
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. The only planned subsequent assessment was at Week 4, end of treatment.
Number and percentage of subjects with abnormal fluorescein angiogram findings
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Baseline (Study Eye) · Abnormal
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Baseline (Study Eye) · Normal
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Baseline (Fellow Eye) · Abnormal
|
21 Participants
|
19 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Baseline (Fellow Eye) · Normal
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Week 4 (Study Eye) · Abnormal
|
18 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Week 4 (Study Eye) · Normal
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Week 4 (Fellow Eye) · Abnormal
|
18 Participants
|
18 Participants
|
|
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Week 4 (Fellow Eye) · Normal
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 2,4,6 and 8 weeksPopulation: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.
Mean and standard deviation of change from Baseline in intra-ocular pressure
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=22 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Study Eye at Week 2
|
-0.1 mmHg
Standard Deviation 2.5
|
1.0 mmHg
Standard Deviation 3.4
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Non-Study Eye at Week 2
|
0.2 mmHg
Standard Deviation 2.6
|
-0.1 mmHg
Standard Deviation 2.8
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Study Eye at Week 4
|
-0.2 mmHg
Standard Deviation 3.1
|
1.2 mmHg
Standard Deviation 2.4
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Non-Study Eye at Week 4
|
0.2 mmHg
Standard Deviation 3.1
|
0.3 mmHg
Standard Deviation 2.6
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Study Eye at Week 6
|
-0.3 mmHg
Standard Deviation 2.9
|
0.2 mmHg
Standard Deviation 2.5
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Non-Study Eye at Week 6
|
0.3 mmHg
Standard Deviation 2.3
|
-0.5 mmHg
Standard Deviation 3.2
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Study Eye at Week 8
|
-0.2 mmHg
Standard Deviation 2.8
|
1.0 mmHg
Standard Deviation 2.0
|
|
Change in Intraocular Pressure From Baseline to Week 8
Change from Baseline in Non-Study Eye at Week 8
|
0.6 mmHg
Standard Deviation 3.2
|
-0.9 mmHg
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 2,4,6 and 8 weeksPopulation: The analysis population is the per protocol population with 19 participants in each dose group at Baseline. One participant in each group missed the Week 4 visit and one participant in the low dose 2.5% group missed the Week 6 visit. Four participants, three in the low dose group and one in the high dose group, were administered rescue medication at clinic visits and their data from subsequent visits are excluded. One participant in each dose group was excluded for having an out-of-window visit.
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=19 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=19 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Change in Central Retinal Thickness (CRT) for Study Eye From Baseline (Day 0) to Week 8
Change from Baseline at Week 2
|
24.9 change from baseline
Standard Deviation 117.3
|
1.3 change from baseline
Standard Deviation 56.5
|
|
Change in Central Retinal Thickness (CRT) for Study Eye From Baseline (Day 0) to Week 8
Change from Baseline at Week 4
|
17.0 change from baseline
Standard Deviation 125.6
|
3.4 change from baseline
Standard Deviation 49.5
|
|
Change in Central Retinal Thickness (CRT) for Study Eye From Baseline (Day 0) to Week 8
Change from Baseline at Week 6
|
-16.3 change from baseline
Standard Deviation 71.1
|
14.9 change from baseline
Standard Deviation 84.5
|
|
Change in Central Retinal Thickness (CRT) for Study Eye From Baseline (Day 0) to Week 8
Change from Baseline at Week 8
|
-46.5 change from baseline
Standard Deviation 101.2
|
14.6 change from baseline
Standard Deviation 110.3
|
SECONDARY outcome
Timeframe: 2, 4, 6 and 8 weeksPopulation: The analysis population is the per protocol population with 19 participants in each dose group at Baseline. One participant in each group missed the Week 4 visit and one participant in the low dose 2.5% group missed the Week 6 visit. Four participants, three in the low dose group and one in the high dose group, were administered rescue medication at clinic visits and their data from subsequent visits are excluded. One participant in each dose group was excluded for having an out-of-window visit.
Outcome measures
| Measure |
SF0166 Low Dose 2.5% BID
n=19 Participants
SF0166 low dose 2.5% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=19 Participants
SF0166 high dose 5.0% instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Change in Best-corrected Visual Acuity (BCVA) for Study Eye From Baseline (Day 0) at Week 4 and Week 8
Change from Baseline at Week 2
|
0.1 change from baseline
Standard Deviation 5.4
|
-0.8 change from baseline
Standard Deviation 4.3
|
|
Change in Best-corrected Visual Acuity (BCVA) for Study Eye From Baseline (Day 0) at Week 4 and Week 8
Change from Baseline at Week 4
|
0.1 change from baseline
Standard Deviation 5.7
|
0.8 change from baseline
Standard Deviation 3.5
|
|
Change in Best-corrected Visual Acuity (BCVA) for Study Eye From Baseline (Day 0) at Week 4 and Week 8
Change from Baseline at Week 6
|
1.1 change from baseline
Standard Deviation 6.1
|
-0.5 change from baseline
Standard Deviation 3.2
|
|
Change in Best-corrected Visual Acuity (BCVA) for Study Eye From Baseline (Day 0) at Week 4 and Week 8
Change from Baseline at Week 8
|
1.6 change from baseline
Standard Deviation 5.2
|
-0.2 change from baseline
Standard Deviation 5.7
|
Adverse Events
SF0166 Low Dose 2.5% BID
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
SF0166 High Dose 5.0% BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SF0166 Low Dose 2.5% BID
n=22 participants at risk
SF0166 low dose 2.5% will be instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 participants at risk
SF0166 high dose 5.0% will be instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
Infections and infestations
Pneumonia
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Sepsis
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
Other adverse events
| Measure |
SF0166 Low Dose 2.5% BID
n=22 participants at risk
SF0166 low dose 2.5% will be instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
SF0166 High Dose 5.0% BID
n=22 participants at risk
SF0166 high dose 5.0% will be instilled in study eye BID for 28 days of treatment.
SF0166 Topical Ophthalmic Solution
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypercoagulation
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Cardiac disorders
Atrial flutter
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
4.5%
1/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
Eye disorders
Vitreous haemorrhage
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Eye disorders
Blepharitis
|
0.00%
0/22 • 8 weeks
|
9.1%
2/22 • 8 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/22 • 8 weeks
|
9.1%
2/22 • 8 weeks
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/22 • 8 weeks
|
9.1%
2/22 • 8 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
General disorders
Non-cardiac chest pain
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
General disorders
Unevaluable event
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Immune system disorders
Hypersensitivity
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Cellulitis
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Oesophageal candidiasis
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Oral candidiasis
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Pharyngitis
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Pneumonia
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Sepsis
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Sinusitis
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Infections and infestations
Foot fracture
|
0.00%
0/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
Investigations
Blood potassium increased
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/22 • 8 weeks
|
9.1%
2/22 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place